Alemtuzumab
- Generic Name
- Alemtuzumab
- Brand Names
- Campath, Lemtrada, MabCampath
- Drug Type
- Biotech
- CAS Number
- 216503-57-0
- Unique Ingredient Identifier
- 3A189DH42V
Overview
Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.
Background
Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.
Indication
用于烷化剂氟达拉滨（fludarabine）治疗失败的B细胞性慢性淋巴细胞白血病患者；亦可用于复发缓解型多发性硬化症治疗。
Associated Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Kidney Transplant Rejection
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Secondary Progressive Multiple Sclerosis (SPMS)
- Steroid Refractory Acute Graft Versus Host Disease
- T-cell Prolymphocytic Leukemia (T-PLL)
- Refractory Autoimmune Hemolytic Anemia
- Refractory Idiopathic thrombocytopenic purpura
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/10/14 | Phase 2 | Recruiting | Paul Szabolcs | ||
2013/06/14 | Phase 3 | Completed | |||
2013/06/11 | Phase 1 | Terminated | |||
2013/03/07 | Phase 2 | Completed | University of Göttingen | ||
2012/12/31 | Phase 4 | Withdrawn | |||
2012/11/20 | Phase 4 | Completed | |||
2012/10/24 | Phase 1 | Terminated | |||
2012/09/05 | Phase 2 | Terminated | Seah Lim M.D. | ||
2012/08/08 | Phase 2 | Active, not recruiting | |||
2012/07/27 | Not Applicable | Recruiting |
FDA Approved Products
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